DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 07/08/26 has been entered in the case. Claims 1-6, 8 are pending for examination; claims 7, 9-15 are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Schreuder (US 4,792,329) in view of Anderson et al. (US 9,456,861).
Regarding claim 1, Schreuder discloses a multi-chamber isolated constituent syringe into a patient. A person skilled in the art would recognize that the syringe in Schreuder can be used for eye surgery, as for intended use purpose for eye treatment;
The multi-chamber isolated constituent syringe 11, in Figs. 1-6 comprising:
a first chamber 22 for accommodating a first constituent 22;
a second chamber 21 distally adjacent the first chamber for accommodating a second constituent 21;
a mixing chamber (at chamber 27) distally adjacent the second chamber 21 to receive the first constituent 22 and the second constituent 21 for mixing the first constituent and the second constituent to form combined mixed constituents therein;
a needle 15 in fluid communication with the mixing chamber 27 & 30 for delivery of the combined mixed constituents into a patient and therefore, the combine mixed constituents can be injected into an eye of a patient as for intended use purpose for eye treatment;
a plunger rod 18 for directing the first and second constituents to the mixing chamber.
Schreuder does not disclose at least one mixing mechanism of the multi-chamber isolated constituent syringe for reaching the mixing chamber; a dual depressor actuator configured to provide separate and simultaneous control of the at least one mixing mechanism and the plunger.
Anderson discloses a multi-chamber isolated constituent syringe 16 comprising: a plunger 52; at least one mixing mechanism 50 of the syringe for reaching a mixing chamber 28; a dual depressor actuator 58 & 98 configured to provide separate and simultaneous control of the at least one mixing mechanism 50 and the plunger 52.
Note: with aspect to the limitation, i.e., configured to provide separate and “simultaneous” control of the at least one mixing mechanism and the plunger is a functional limitation and method of using “simultaneous”, therefore, it is considered as functional limitation to performing a function. In this case, the dual depressor actuator 58 & 98 can be performed simultaneous control the mixing mechanism and the plunger such as: one hand pushing the actuator 98 and other hand pushing the actuator 58 at same time.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plunger assembly of Schreuder to include a dual depressor actuator. This actuator includes a mixing mechanism engaged with the plunger, as taught by Anderson, to facilitate rapid displacement of the first and second constituents into the mixing chamber. This modification mixes the two constituents uniformly to reduce the amount of material left behind in the syringe.
Regarding claim 3, Schreuder in view of Anderson discloses all the claimed subject matter as required. Schreuder discloses that a syringe can be used to accommodate a solid medicament in the space between the separating stopper/barrier, col. 4, lines 50-57; wherein a lyophilized medicament (the solid medicament) is provided in a front chamber (similar to the second chamber 21 in Schreuder). In other words, Schreuder in view of Anderson discloses the first chamber 22 is a wet chamber and the first constituent is a liquid and the second chamber 22 is a dry chamber and the second constituent is a dry constituent.
Regarding claim 4, Schreuder in view of Anderson discloses all the claimed subject matter as required. Applicant states in the Background of the Invention that it is well-known in the art to form a retinal patch that include a mixture of different constituent components that, upon mixing a solid polyethylene power mix combine with a liquid polyethylene, para [0005] in the original specification of the current application. Therefore, a person skilled in the art would recognize that the syringe in Schreuder in view of Mills can be obtain a polymer solution in the first/liquid chamber and a dry polymer in the second/dry chamber.
With regarding the volume 2.0 ml of polymer solution and 0.10 ml of dry powder, the instant disclosure describes these parameters (2.0 ml of polymer solution and 0.10 g of a dry polymer) does not describe it as contributing any unexpected result to the mixture of two constituents. As such, these parameters are deemed matter of design choice for certain eye treatment, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
In addition, the retina patch size depends on the specific blend of liquid and dry polymers used, allowing for customized treatment based on the patient’s eyes repair need. Therefore, these parameters as required in the claim 4 is considered as intended use purpose.
Regarding claim 5, Schreuder in view of Anderson discloses all the claimed subject matter as required. Schreuder in view of Anderson discloses that the mixing chamber (at chamber 27 & 30) accommodated dedicated airspace of a volume (e.g., emptied space before mixture of the two constituents) tailored to the first and second constituents for mixing.
Regarding claim 6, Schreuder in view of Anderson discloses all the claimed subject matter as required. Schreuder in view of Anderson discloses that wherein the mixing mechanism (as modified by Anderson) is an auger implement 70 coupled to a plunger for breaching the barriers/separating stoppers with the constituents.
Regarding claim 8, Schreuder in view of Anderson discloses all the claimed subject matter as required. Schreuder in view of Anderson discloses that a dual depressor actuator 58/98 is disposed at an external location of a housing accommodating the first and second chambers and the mixing chamber.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schreuder (US 4,792,329) in view of Anderson et al. (US 9,456,861) and further in view of Tan (US 7,43,237).
Schreuder in view of Anderson discloses all the claimed subject matter as required. Schreuder in view of Mills discloses that the chambers are isolated from one another by barrier/stopper. Schreuder in view of Mills fails to disclose that the barrier/stopper are selected from a group consisting of medical foil, a pressure degradable membrane and a rupture disk.
Tan discloses a syringe comprising: a first chamber 280; a second chamber 290; wherein the chambers are isolated from one another by barrier 250 selected from a group of rupture disk, see Fig. 2E.
Since Schreuder and Tan are both from the same field of endeavor, the purpose disclosed by Tan would have been recognized in the pertinent art of Schreuder.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify barrier/stopper of the device of Schreuder in view of Anderson with providing a weaken and rupture disk as being used as a separating barrier/stopper, as taught by Tan, in order to facilitate rapid displacement of the first constituent from the first chamber into the second chamber.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8 have been considered but are moot because the new ground of rejection. Please see the rejection above for more details.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
Prosecution Insights